Time to Tumor Growth: A Model End Point and New Metric System for Oncology Clinical Trials
A partir de données de deux essais de phase III évaluant l'intérêt d'ajouter le bévacizumab à une chimiothérapie de première ligne et incluant au total 1 126 patients occidentaux ou asiatiques atteints d'un cancer colorectal, cette étude évalue l'association entre des paramètres liés à la croissance tumorale et la survie globale des patients
There has been extensive societal investment in oncology drug discovery and development during the past decade. However, there has been limited innovation in clinical trial design during the same period, both in the private sector and in government-sponsored clinical trials, especially with regard to end point evaluation. Innovations in clinical trial design could accelerate availability of effective new drugs and reduce the rate of failure in expensive late-phase development, and therefore reduce the overall costs of oncology drug development. Although there have been some changes, such as the increaseduseofprogression-freesurvival (PFS) as a primary end point for phase II trials, almost all trials (including those with PFS end points) continue to use the RECIST criteria, which distinguish progressive disease or partial response from stable disease by arbitrary dividing lines, rather than using the actual richness of the carefully collected radiologic data.
Journal of Clinical Oncology , éditorial en libre accès, 2013